14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MBA Biotech Implant System
FDA 510(k)
FDA Class 2
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776191122·Nathanson Liver Retractor Medium
PEAK MEDICAL
FDA UDI
Peak Medical Distribution Inc.·G45352430020·Nathanson Style Liver Retractor, 5MM DIA - Size...
ELMED
FDA UDI
ELMED INCORPORATED·00842180150096·ELMED NATHANSON STYLE LIVER RETRACTORS, 5MM DIA...
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105306·SARKISIAN-WESTCOTT SCISSORS SM W/ MARKS
Flexi-Flange Fiber
FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054001393·Flexi-Flange Fiber Refill Kit Size 2
ELMED
FDA UDI
ELMED INCORPORATED·00842180169944·5MM ELMED NATHANSON STYLE LIVER RETRACTORS, MED...
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
Metallic Locking Bone Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FGB·November 20, 2008
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
WHITE RELOAD FOR ECHELON
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2013
PROCEED MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 5, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025